Effects of an Immersive Virtual Reality Intervention Combined With Mindfulness-based Stress Reduction

Stress Clinical Trial

Official title:

Effects of an Immersive Virtual Reality Intervention Combined With Mindfulness-based Therapy on Mental Health in Nurses During the COVID-19 Pandemic: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05517148
• Other study ID #: SJCX22_0701
• Status: Completed
• Phase: N/A
• Start date: September 25, 2022
• Est. completion date: January 30, 2023

Study information

• Verified date: May 2023
• Source: Nanjing University of Traditional Chinese Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Mindfulness-based stress reduction (MBSR), a widely used method to improve mental state and sleep quality, was developed by Kabat-Zinn in 1970. The meditation of MBSR is effective in regulating patients' emotions, leading to reduced stress, pain, and psychological symptoms. Studies have demonstrated that MBSR has a positive impact on multiple psychological and physical symptoms in a variety of cancers. On this basis, investigators found that VR treatment can also help patients relax, and it has been widely used in cancer symptom relief in recent years. VR treatment involves using headset devices that fully restrict the vision field to content displayed inside the headset screen; As a treatment modality, VR provides a unique environment comprising 3D visually immersive experiences that are enriched with stereo sounds and elements such as rich colors and scenic environments that enhance elicitation of desired states of arousal and affect. Within the therapeutic context, VR may be flexibly designed and tailored to address the needs of specific conditions (eg, anxiety, depression, pain) auditory perception is not fully restricted, though the corresponding device-delivered auditory content commands attention.

Description:

Recently, studies have revealed that individuals who have survived a COVID-19 infection may experience a range of persistent symptoms (Comelli et al., 2022; Nalbandian et al., 2021), indicating that the pandemic is far from over and its aftermath is difficult to eliminate completely. At the same time, the COVID-19 pandemic has presented unprecedented challenges for nurses around the world. Not only are they at the forefront of preventing and controlling the spread of the virus, but they are also the primary caregivers for patients experiencing the after-effects of the pandemic. Meanwhile, they also need to care for the patients with other illness. Some study evidence indicated that there is a shortage of nurses during the COVID-19 pandemic, and nursing staff are experiencing a high level of negative emotions (Jiang et al., 2022; Zhang et al., 2022). The ongoing pandemic has had a huge impact on the mental health and work of nurses (Chen et al., 2021). Between 40% and 66.7% of surveyed health care workers reported mental health problems during the pandemic, according to a report by the OECD (Organisation for Economic Development and Cooperation, 2021). The stress caused by COVID-19 has contributed to workforce attrition, with many nurses opting to leave the profession (Organisation for Economic Development and Cooperation, 2021; World Health Organization, 2022). It has taken a heavy toll on the healthcare system. Maintaining the mental health of nurses is crucial. This is not only conducive to pandemic prevention and control, but also plays a significant role in the normal medical order.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: January 30, 2023
• Est. primary completion date: January 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Registered nurses (RNs) working in target departments, working in target departments, including. The target departments mainly included internal medicine, surgical, emergency department, were included in this study. These nurses had direct contact with COVID-19 patients, making them more susceptible to experiencing negative mental health effects due to increased work pressure. Predefined exclusion criteria included serious carsickness reaction, psychological crisis with a definite diagnosis, and not being engaged in nursing work related to COVID-19. Nurse managers in different departments recommended participants for the study, and interested nurses were contacted to provide basic information and complete evaluation content. Recruitment took place in September 2022. We recorded the enrolled nurses, related basic information and outcome measures.

Related Conditions & MeSH terms

• COVID-19
• COVID-19 Pandemic
• Nurse's Role
• Stress

Intervention

Device:
• Therapeutic VR
Treatment module categories included: (1) Mindfulness-based stress reduction training: an audio conducting practice with breathing-based biofeedback training in immersive and interactive environments to support self-regulation and relaxation.

Locations

Country	Name	City	State
China	siting YANG	Nanjing	Jiangsu
China	YANG Siting	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Nanjing University of Traditional Chinese Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Hamilton Anxiety Rating Scale (HAM-A)	The HAM-A contains items, each scored on a 5-point scale (0, asymptomatic; 1, mild symptoms; 2, moderate symptoms; 3, severe symptoms; 4, extremely severe symptoms). The total sum score, ranging from 0 to 56, can be classified into four levels: 0, no anxiety symptoms; 1-17, mild anxiety; 18-24, moderate anxiety; 25-56, severe anxiety	up to 8 weeks
Primary	Depression, anxiety, and stress scale (DASS-21)	The questionnaire of the Chinese version of DASS-21 comprises 21 items that assess three negative emotional experiences, namely depression, anxiety, and stress (Jiang et al., 2021). The depression factor consists of seven items (3, 5, 10, 13, 16, 17, 21), which are related to pathological dysthymia, low self-esteem, and low level of positive emotions. The anxiety factor comprises seven items (2, 4, 7, 9, 15, 19, 20), that related to the somatic and subjective experience of anxiety arousal. The stress factor includes seven items (1, 6, 8, 11, 12, 14, 18), that relate to negative emotionally. A 4-point score System was used (0=completely disagree, 1=partially agree, 2=mostly agree, 3=completely agree). Higher scores indicate stronger negative emotional experiences (Gomez et al., 2014; Oei et al., 2013).	up to 8 weeks
Secondary	Work-related emotional score (WRE)	Nurses were asked to select a level of their mood at work during the COVID-19 to reflect their emotional attitude or degree of satisfaction towards work. The question posed was, "Has COVID-19 affected your mood at work?". The subjective scores range from 0 (no affected) to 10 (extremely affected).	up to 8 weeks

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